Notified body meaning

In this issue: New technologies Internet Data protection Media Advertising, marketing and sponsorship Reputation management Telecommunications LexTalk®TMT: a Lexis®Nexis community Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information New technologies DSIT releases report and impact assessment on copyright and artificial intelligence DSIT, the Department for Culture, Media and Sport (DCMS) and the Intellectual Property Office have jointly issued a report and an impact assessment exploring the use of works protected by copyright in the training and development of AI systems. These have been published pursuant to sections 135 and 136 of the Data (Use and Access) Act 2025. See: LNB News 18/03/2026 44. EDPS unveils Compass on supervision and enforcement under the EU AI Act The European Data Protection Supervisor (EDPS) has released its Compass setting out its expanded role under the EU AI Act as a market surveillance authority...

When is a medical device including AI subject to the EU AI Act? Any medical device that is, or incorporates, an AI system as defined by the EU AI Act, and is intended for the EU market, must comply with the Act’s rules. The term ‘AI system’ is interpreted broadly and can encompass solutions that leverage big data to generate, for example, reasonably accurate predictions of an indication, even if they are not strictly what many would regard as artificial intelligence. As a consequence, many medical devices already available are captured within the Act’s scope... Medical devices and high- or limited-risk AI systems under the EU AI Act Medical devices may fall into high-risk or otherwise limited-risk categories. High-risk devices are subject to a more demanding regulatory framework that, in addition to medical device regulation obligations, requires Notified Body certification of the AI system. There are two pathways for medical devices to be classified as high-risk AI systems (HRAIS)...

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NOTE—to check whether notification thresholds in Vietnam and worldwide are triggered, please consult: Where to Notify. 1. Have there been any recent developments regarding the Vietnamese merger control regime and are any updates/developments expected in the coming year? Are there any other ‘hot’ merger control issues in Vietnam? In 2020, Vietnam promulgated Decree 35 on Detailed Regulations for Implementation of the Law on Competition dated 24 March 2020 (Decree 35), which became effective on 15 May 2020. This marked a pivotal step in putting into operation the competition framework envisaged under the Law on Competition dated 12 June 2018 (Competition Law). The body designated under the Competition Law, the Vietnam Competition Committee (VCC), was established on 1 April 2023 and from that date assumed responsibility for the merger control regime. Decree 35 introduced the following clarifications to merger control: Notification thresholds, under which a transaction must be notified where: the total assets or turnover in Vietnam of...

1. What is the applicable legislation? On 13 November 2025, the Act on Screening of Foreign Investments, Official Gazette No 136/2025 (FDI Act 2025), took effect. 2. Which government or other body (or bodies) reviews foreign investments? Under the FDI Act 2025, foreign investments are examined through a two-tier process involving the Ministry of Finance and an FDI Commission. On 13 November 2025, the Act on Screening of Foreign Investments, Official Gazette No 136/2025 (FDI Act 2025), took effect. The Ministry of Finance serves as the principal authority, issuing the ultimate administrative ruling on a notified foreign investment, based on the FDI Commission’s opinion. 3. What is the scope of the foreign investment regime? Does it only apply to specific sectors or types of investors (e.g. foreign or non-EU / non-WTO)? Are there specific rules for certain types of investors (e.g. state-owned enterprises)? In general, the Croatian foreign investment regime concentrates on reviewing foreign investments in restricted sectors to safeguard national security and/or public order....

A conversation with Diego Peralta Valenzuela, partner, and Vesna Camelio Ursic, senior associate, from Carey y Cía. Limitada on key issues regarding foreign direct investment (FDI) control in Chile 1. What is the applicable legislation? Chile’s equity foreign investment framework is principally shaped by two instruments: Chapter XIV of the Compendium of Foreign Exchange Regulations of the Central Bank of Chile (Compendium of Foreign Exchange Regulations) Law No. 20,848 The Compendium of Foreign Exchange Regulations-promulgated by the Central Bank of Chile under the authority granted by its Constitutional Organic Law-sets out the overarching rules for foreign exchange dealings. These provisions are binding on entities within the Formal Exchange Market (as defined by the Central Bank’s Constitutional Organic Law). The Compendium also extends to non-bank entities, including natural persons, and imposes certain constraints on significant cross-border exchange operations that affect Chile’s balance of payments and capital account. In particular, it mandates that designated transactions be notified in writing to the Central Bank...

Insert the following definitions as new definitions into clause 1 of Precedent: Share purchase agreement—pro-seller—individual sellers—unconditional—long form: 1 Definitions and interpretation Sanctioned Activity • any conduct subject to sanctions set by a Sanctioning Body; Sanctioning Body • the UK, USA, EU and any other relevant authority imposing/administering sanctions; Sanctioned Entity • any person or entity that is, or is owned/controlled (directly or indirectly, per Sanctions Laws) by, a party sanctioned or listed by a Sanctioning Body; Sanctions Laws • all applicable law on Sanctioned Activities binding any Party or this Agreement’s performance; Sanctions Policy • the Sellers’ sanctions policy in Appendix [ insert Appendix number ], as updated and notified to the Buyer; 1.2 The Sellers and the Group Companies, as at the date of this Agreement and throughout its term: are not Sanctioned Entities; have not been notified of any investigation into a Sanctioned Activity; are unaware of Business circumstances that could give rise...

Insert the following definitions as new definitions into clause 1 of Precedent: Share purchase agreement—pro-buyer—corporate seller—conditional—long form: 1 Definitions and interpretation Sanctioned Activity: activity subject to a Sanctioning Body’s sanctions. Sanctioning Body: United Kingdom, United States of America, European Union, and any other authority administering sanctions. Sanctioned Entity: any person or entity that is, or is owned or controlled (directly or indirectly) by one that is, sanctioned or on a designated list of a Sanctioning Body; ‘owned or controlled directly or indirectly’ has the meaning in Sanctions Laws. Sanctions Laws: all law on a Sanctioned Activity binding either Party or the Agreement’s performance. Sanctions Policy: the Seller’s sanctions policy in Appendix [insert Appendix number], as updated and notified to the Buyer. is not a Sanctioned Entity; has not been notified of any Sanctioned Activity investigation; is unaware of Business circumstances likely to prompt such investigation; shall comply with Sanctions Laws and the Sanctions Policy; ...

1 Definitions and interpretation Sanctioned Activity: activity subject to sanctions by a Sanctioning Body; Sanctioning Body: the UK, United States of America, EU, and any other competent authority imposing or administering sanctions; Sanctioned Entity: any person or entity sanctioned or designated by a Sanctioning Body, or owned or controlled (directly or indirectly) by one that is; Sanctions Laws: law on a Sanctioned Activity applying to either Party or this Agreement’s performance; Sanctions Policy: the Seller’s sanctions policy in Appendix [ insert Appendix number ], as updated and notified to the Buyer; 1.3 The Seller During this Agreement, the Seller and each member of the Seller’s Group [ , including their officers, employees, agents or sub-contractors, ]: is not a Sanctioned Entity; has not been notified of an investigation into a Sanctioned Activity; is unaware of Business-related circumstances that could trigger such an investigation; shall comply at all times with Sanctions Laws and Sanctions...